evaluating the safety and efficacy of romiplostim (amg 531) in thrombocytopenic subjects with immune thrombocytopenic purpura (itp)

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: the primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with itp.


Eligibility criteria:
inclusion criteria: * diagnosis of itp according to american society of hematology (ash) guidelines at least 3 months before enrollment * have completed at least 1 prior treatment for itp * two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following: * less than 30 x 10\^9/l for those subjects not receiving any itp therapy, * less than 50 x 10\^9/l for those subjects receiving any itp therapy * eastern cooperative oncology group performance status of 0 to 2 * serum creatinine concentration ≤ 2 mg/dl (≤ 176.8 µmol/l) * adequate liver function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range * hemoglobin greater than 10.0 g/dl * written informed consent exclusion criteria: * considered a substantial risk for adverse outcomes because of a clinically important trend (as determined by the investigator) detected in the platelet counts during the screening period * any known history of bone marrow stem cell disorder * any active malignancy. if prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization * documented diagnosis of arterial thrombosis (ie, stroke, transient ischemic attack, or myocardial infarction) in the previous year; history of venous thrombosis (ie, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy * unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[new york heart association (nyha) greater than class ii\], uncontrolled hypertension \[diastolic greater than 100 mmhg\] or cardiac arrhythmia) * have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker using oral contraceptives; hypercholesteremia (\> 240 mg/dl); treatment for hypertension * known positive test for human immunodeficiency virus (hiv) infection or hepatitis c virus * received any treatment for itp (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit * received intravenous (iv) immunoglobulin (ig) or winrho within 2 weeks before the screening visit * received hematopoietic growth factors, including interleukin (il)-11 (neumega®) within 4 weeks before the screening visit * past or present participation in any study evaluating polyethylene glycol recombinant human magakaryopoiesis differentiating factor (peg-rhumgdf), recombinant human thrombopoietin (rhutpo), or related platelet product * received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study * received any monoclonal antibody (eg, rituximab) within 16 weeks before the screening visit or anticipated use during the time of the proposed study * less than 4 weeks since receipt of any therapeutic drug or device that is not fda approved for any indication before the screening period * less than 2 months since major surgery (including laparoscopic splenectomy) * pregnant or breast feeding * subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator

Keywords: immune thrombocytopenic purpura idiopathic thrombocytopenic purpura thrombocytopenic thrombocytopenia itp